Retrospective Analysis of Spray Skin Treats for Severe Burns

A Real-world 10-year Single Center Experience With Spray Skin in the Treatment of Extensive Severe Burns

This study investigated the efficacy of novel approach spray skin for extensive severe burns treatment.

Study Overview

• Status: Completed
• Conditions: Morality; Skin Graft Complications
• Intervention / Treatment: Procedure: spray skin; Procedure: Control group

Detailed Description

Burns are a global public health problem. This study investigated the efficacy of novel approach spray skin (autologous skin cell suspension combined with split-thickness skin grafting, STSG) for extensive severe burns treatment.

We performed a real-world retrospective analysis of extensive burns patients (> 50% TBSA) from our hospital last 10 years.

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

severe burns patients with > 50% TBSA

Description

Inclusion Criteria:

• patients with > 50% TBSA

Exclusion Criteria:

• died within 1 week after admission
• admitted to hospital more than 1 week after injury

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
experimental gourp; The patients who used the autologous skin cell suspension combined with skin grafting.	Procedure: spray skin; The patients who used the autologous skin cell suspension combined with skin grafting.
Control group; The patients who used split-thickness skin grafting.	Procedure: Control group; The patients who used skin grafting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival rate	Patient survival during hospitalization	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication of skin graft	the survival of grafting skin	the take rate in the postoperative day 30, 60, 90
length of hospital	The time during which the patient was hospitalized	through study completion, usually no more than 6 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Principal Investigator: Jiayuan Zhu, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 3, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: spray skin, severe burn, microskin grafting
• Other Study ID Numbers: SYSU-FAH-2019287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Subjects' private information needs to be protected, and contact the investigator if necessary.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No